Extracorporeal photopheresis kits for transfusion medicine

This is a notice of intent, not a request for a quotation. A solicitation document will not be issued and quotations will not be requested.

The National Institute of Health (NIH), Clinical Center (CC) intends to award a one year fixed price purchase order to Therakos, Inc., West Chester, PA on a sole source basis to procure UVAR XTS® System Procedural Kits - XT125, for extracorporeal photopheresis therapy to patients post stem-cell transplantation on the existing government owned THERAKOS® UVAR XTS® Photopheresis System Instrument. This purchase is required for the analysis of patients with confirmed acute graft-versus-host disease per protocol 15-C-0039. Extracorporeal Photopheresis (ECP) is a recognized therapy for graft-versus-host disease (GVHD) post stem cell transplantation, particularly the steroid-refractory patient population. Under protocol 15-C-0039, ECP is delivered at a strategic time-point in patients' therapy. Typically this therapy is in conjunction with other acute GVHD modalities. The goal of this treatment is to contribute to the patient's transition from an acute inpatient therapy to outpatient maintenance therapy.

Only one known vendor has been identified for the one year requirement of 52 cases of the UVAR XTS® System Procedural Kits-XT125. Therokos Inc. is the registered trademark holder and sole manufacturer of the required product. If this specific product is not received, patients could be potentially harmed causing an increased risk for post-stem-cell transplant complications, infection and death.

This acquisition is being conducted using policies unique to the test program for commercial items prescribed in FAR Subpart 13.5. Interested concerns capable of providing the same or similar products or services as described in this notice may submit a capability statement outlining their capabilities. Capability Statements must be received within the time set forth in this synopsis to be considered by the Government. A determination to compete this proposed contract based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.

Each response should include the following Business Information:
a. DUNS.
b. Company Name, address, POC, Phone and Email address
c. Current GSA Schedules or NAICS codes appropriate to this Award.
d. Type of Company (i.e., small business, 8(a), woman owned, hubZone, veteran owned, etc.) as validated in System For Award Management (SAM). All offerors must register on the SAM located at http://www.sam.gov/portal/SAM/#1
e. Capability Statement

Comments to this announcement may be submitted to the Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Malinda Dehner, Contract Specialist, dehnerm@cc.nih.gov by the due date and time marked in this notice.